Nightstar Therapeutics Announces Initiation of STAR Phase 3 Registrational Trial for NSR-REP1 in Choroideremia
NIGHTSTAR THERAPEUTICS PLC AMERICAN DEPOSITARY SHA (NITE)
Last nightstar therapeutics plc american depositary sha earnings: 11/13 01:00 am
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Source: GlobeNewswire
LEXINGTON, Mass. and LONDON, March 05, 2018 (GLOBE NEWSWIRE) -- Nightstar Therapeutics plc (NASDAQ:NITE), a clinical-stage gene therapy company developing treatments for rare inherited retinal diseases, today announced the initiation of the company’s STAR Phase 3 registrational trial to study the safety and efficacy of NSR-REP1 in patients with choroideremia. In data from 32 patients treated with NSR-REP1 across four open-label Phase 1/2 clinical trials, over 90% of treated patients maintained or improved their visual acuity over a one-year follow-up period. The STAR trial is expected to enroll approximately 140 patients across 18 clinical sites in the United States, Europe, Canada and South America, of which six sites will be surgical centers. Eligible patients will be randomized into one of three study arms: 56 patients receiving a high-dose of NSR-REP1 in one-eye (1.0 × 10^11 genome particles, or gp); 28 patients receiving a low-dose of NSR-REP1 in one-eye (1.0 × 10^10 gp); and
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